Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


Course Details & Registration Information

Course
Fundamentals of Microbiology
Name
SEF-147CL
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Description
The application of fundamental microbiological concepts and identification techniques are critical for a wide range of manufacturing processes regulated by the FDA, USDA, and other agencies. These include producers of pharmaceutical, food, beverage, and dietary supplement products. This course covers the basic theories and techniques of bacteria and fungi detection, isolation, enumeration, and identification of microorganisms commonly found in industrial settings. Also included are regulatory requirements, methods and rationale for environmental monitoring assessments, reporting, and microbiological quality control. Materials will be covered through a combination of informational lectures and hands-on laboratory exercises.
Course Objectives
  1. Be able to define a wide range of fundamental microbiological concepts and theories that are critical to regulated industries of pharmaceutical, food, and dietary supplements.
  2. Be able to explain and demonstrate fundamental techniques of isolation, detection, enumeration, and identification of bacteria and fungi commonly found in industrial settings.
  3. Be able to summarize: features of organisms of interest, environmental monitoring rationale, regulatory requirements, standard methodology, and resources available for interpretation of laboratory results.
  4. Have experience in evaluation of results, reporting and quality control.
  5. Be able to describe rapid methodologies and special interest microbiology topics.
Outline of Instruction
  1. Day 1, Morning Lecture (4 hours)
    1. Introductions, Questionnaires, Pre-course test, Brief Job Description, Goals for Class
    2. Laboratory Safety –BSL 1 and 2 practices
    3. Gold Standard Methods
    4. Introduction to Industrial Microbiology and Bacteria
    5. Colony Morphology, Cell shape, and Gram stain
    6. Quality Control Laboratory Testing
  2. Day 1, Afternoon Laboratory Exercise (4 hours)
    1. Aseptic suite water collection- demo
    2. Aseptic technique practice
  3. Day 2, Morning Lecture (4 hours)
    1. Historical perspective on bacterial identification
    2. Historical understanding of Microbiology
    3. Enumeration (USP 61, FDA BAM)
    4. Preliminary Identification
    5. Medical and Industry Important Fungi
  4. Day 2, Afternoon Laboratory Exercise (4 hours)
    1. Examine previous day tests
    2. Microscopy
    3. Enumeration
    4. Endotoxin- Gel Clot Method (USP 85)
    5. Serology (FDA BAM) demo (hands on time permitting)
    6. Supplemental rapid tests
  5. Day 3, Lecture (1 hour)
    1. Special Topic Microorganisms
    2. Mycoplasma (USP 63)
    3. Viruses (FDA BAM)
    4. Rapid Methods/Confirmatory Microbiology
  6. Day 3, Laboratory Exercise (2 hours)
    1. Examine previous day tests
    2. Complete Laboratory Report
    3. Environmental Monitoring
    4. Group Lab Report presentations and discussion
  7. Day 3, Lecture (1 hour)
    1. Assessment
    2. Review results as a group
    3. Discuss issues presented in assessment
    4. Conclusions and Final Discussion
    5. Open floor for additional questions
    6. Course evaluations
Contact Hours
20
CEU's
2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 80% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager